Publication:
Improving the radical cure of vivax malaria (IMPROV): A study protocol for a multicentre randomised, placebo-controlled comparison of short and long course primaquine regimens

Issued Date

2015-12-07

Resource Type

Article

ISSN

14712334

DOI

10.1186/s12879-015-1276-2

Other identifier(s)

2-s2.0-84952865125

Rights

Mahidol University

Rights Holder(s)

SCOPUS

Bibliographic Citation

BMC Infectious Diseases. Vol.15, No.1 (2015)

Suggested Citation

Tesfay Abreha, Bereket Alemayehu, Ashenafi Assefa, Ghulam Rahim Awab, J. Kevin Baird, Beay Bezabih, Phaik Yeong Cheah, Nicholas P. Day, Angela Devine, Mehul Dorda, Arjen M. Dondorp, Samuel Girma, Tran Tinh Hien, Daddi Jima, Moges Kassa, Amha Kebende, Naw Htee Khu, Toby Leslie, Benedikt Ley, Yoel Lubell, Ismail Mayan, Zenebe Meaku, Ayodhia P. Pasaribu, Nguyen Hoan Phu, Ric N. Price, Julie A. Simpson, Hiwot Solomon, Inge Sutanto, Yehualahet Tadesse, Bob Taylor, Ngo Viet Thanh, Kamala Thriemer, Lorenz von Seidlein, Nicholas White, Adugna Woyessa, Prayoon Yuentrakul, Rohullah Zekria Improving the radical cure of vivax malaria (IMPROV): A study protocol for a multicentre randomised, placebo-controlled comparison of short and long course primaquine regimens. BMC Infectious Diseases. Vol.15, No.1 (2015). doi:10.1186/s12879-015-1276-2 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/36220

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Title

Improving the radical cure of vivax malaria (IMPROV): A study protocol for a multicentre randomised, placebo-controlled comparison of short and long course primaquine regimens

Author(s)

Tesfay Abreha
 Bereket Alemayehu
 Ashenafi Assefa
 Ghulam Rahim Awab
 J. Kevin Baird
 Beay Bezabih
 Phaik Yeong Cheah
 Nicholas P. Day
 Angela Devine
 Mehul Dorda
 Arjen M. Dondorp
 Samuel Girma
 Tran Tinh Hien
 Daddi Jima
 Moges Kassa
 Amha Kebende
 Naw Htee Khu
 Toby Leslie
 Benedikt Ley
 Yoel Lubell
 Ismail Mayan
 Zenebe Meaku
 Ayodhia P. Pasaribu
 Nguyen Hoan Phu
 Ric N. Price
 Julie A. Simpson
 Hiwot Solomon
 Inge Sutanto
 Yehualahet Tadesse
 Bob Taylor
 Ngo Viet Thanh
 Kamala Thriemer
 Lorenz von Seidlein
 Nicholas White
 Adugna Woyessa
 Prayoon Yuentrakul
 Rohullah Zekria

Other Contributor(s)

Columbia University Mailman School of Public Health
 Columbia University Medical Center
 Ethiopian Public Health Institute
 Nangarhar Medical Faculty of Nangarhar University
 Eijkman-Oxford Clinical Research Unit
 Nuffield Department of Clinical Medicine
 Amhara Regional Health Bureau
 Mahidol University
 Worldwide Antimalarial Resistance Network (WWARN)
 UCL
 London School of Hygiene & Tropical Medicine
 Health Protection and Research Organization
 Menzies School of Health Research
 Universitas Sumatera Utara
 University of Melbourne
 Federal Ministry of Health - Ethiopia
 Universitas Indonesia

Abstract

© 2015 The IMPROV Study Group. Background: Plasmodium vivax malaria is a major cause of morbidity and recognised as an important contributor to mortality in some endemic areas. The current recommended treatment regimen for the radical cure of P. vivax includes a schizontocidal antimalarial, usually chloroquine, combined with a 14 day regimen of primaquine. The long treatment course frequently results in poor adherence and effectiveness. Shorter courses of higher daily doses of primaquine have the potential to improve adherence and thus effectiveness without compromising safety. The proposed multicentre randomised clinical trial aims to provide evidence across a variety of endemic settings on the safety and efficacy of high dose short course primaquine in glucose-6-phosphate-dehydrogenase (G6PD) normal patients. Design: This study is designed as a placebo controlled, double blinded, randomized trial in four countries: Indonesia, Vietnam, Afghanistan and Ethiopia. G6PD normal patients diagnosed with vivax malaria are randomized to receive either 7 or 14 days high dose primaquine or placebo. G6PD deficient (G6PDd) patients are allocated to weekly primaquine doses for 8 weeks. All treatment is directly observed and recurrent episodes are treated with the same treatment than allocated at the enrolment episode. Patients are followed daily until completion of treatment, weekly until 8 weeks and then monthly until 1 year after initiation of the treatment. The primary endpoint is the incidence rate (per person year) of symptomatic recurrent P. vivax parasitaemia over 12 months of follow-up, for all individuals, controlling for site, comparing the 7 versus 14-day primaquine treatment arms. Secondary endpoints are other efficacy measures such as incidence risk at different time points. Further endpoints are risks of haemolysis and severe adverse events. Discussion: This study has been approved by relevant institutional ethics committees in the UK and Australia, and all participating countries. Results will be disseminated to inform P. vivax malaria treatment policy through peer-reviewed publications and academic presentations. Findings will contribute to a better understanding of the risks and benefits of primaquine which is crucial in persuading policy makers as well as clinicians of the importance of radical cure of vivax malaria, contributing to decreased transmission and a reduce parasite reservoir. Trial registration: ClinicalTrials.gov Identifier: NCT01814683. Registered March 18, 2013

Keyword(s)

Medicine

Availability

URI

https://repository.li.mahidol.ac.th/handle/20.500.14594/36220

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Scopus 2011-2015